Human Subject Research Specialist II

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

4901 Lac de Ville Blvd, Ste 120, Brighton, New York, United States of America, 14618

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400104 Neurology Movement Disorders

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$24.91 - $34.87

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

With considerable latitude for independent judgment, coordinates all aspects of assigned human subject research studies involving Spanish-speaking patients for the department of Neurology Movement Disorders division.

Typically, responsible for the successful coordination of complex interventional or large multi-site clinical drug trials. Receives delegation of study tasks from multiple Principal Investigators and works as an integral part of the research team. May provide mentorship to Human Subject Research Specialist I.

ESSENTIAL FUNCTIONS

Study Visits:

Recruits, consents, schedules, and conducts research subject visits for complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.

• Develops, implements, and evaluates subject recruitment and retention strategies. 
• Consents subjects to assigned research studies
• Schedules and facilitates visits, performing study related procedures as outlined in protocol
• Draws blood and performs testing such as ECG, timed mobility tests, and cognitive function tests, depending on the protocol
• Coordinates and documents dispensing and returning of study drugs/materials
• Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities
• Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation

Mentoring:

Mentors and trains Human Subject Research Specialist I (HSRS I) on activities related to conducting human subject research.

• Provides study-specific training, oversight, and back-up support.
• Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.
• Mentors on activities specific to conducting research for complex studies.
• Completes annual performance evaluations/reviews for HSRS I.

Regulatory Oversight:

Oversees and manages the regulatory details for multiple assigned research studies.

• Creates, modifies, organizes, and maintains study documentation for the regulatory file
• Manages and submits study applications, amendments, and continuing reviews for IRB approval
• Ensures compliance with all applicable regulatory and institutional requirements and standards
• Ensures the integrity and security of all study documents at all times
• Initiates, monitors, and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified

Liaison:

Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration.

• Maintains continuous communication with all relevant stakeholders.
• Troubleshoots and resolves issues in a timely manner
• Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol
• Represents the University and Principal Investigator at study meetings as needed

Data Management:

Develops and/or manages databases (e.g., EDC) for research studies.

• Develops, implements, and monitors systems and methods to ensure data integrity
• Ensures data is entered in a timely manner and database(s) is up to da